Roche Diagnostics Corp. - FDA 510(k) Cleared Devices
264
Total
263
Cleared
1
Denied
264 devices
Cleared
Nov 29, 2002
ELECSYS PROBNP CALCHECK
Chemistry
256d
Cleared
Nov 25, 2002
COBAS INTEGRA ONLINE DAT II COCAINE II
Toxicology
54d
Cleared
Nov 19, 2002
ELECSYS PROBNP IMMUNOASSAY
Chemistry
112d
Cleared
Oct 25, 2002
PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422
Hematology
193d
Cleared
Oct 24, 2002
PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND...
Hematology
224d
Cleared
Sep 09, 2002
ELECSYS CORTISOL TEST SYSTEM
Chemistry
145d
Cleared
Aug 29, 2002
MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB
Chemistry
20d
Cleared
Aug 05, 2002
ELECSYS ANTI-TG TEST SYSTEM
Immunology
157d
Cleared
Jul 23, 2002
ACCU-CHEK COMPACT SYSTEM
Chemistry
20d
Cleared
Jul 16, 2002
ONLINE DAT II METHADONE II
Toxicology
68d
Cleared
Jul 16, 2002
COBAS INTEGRA ONLINE DAT II METHADONE II
Toxicology
68d
Cleared
Jul 12, 2002
ROCHE ONLINE GENTAMICIN
Toxicology
130d
Cleared
Jul 03, 2002
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
Chemistry
29d
Cleared
Jun 11, 2002
ACCU-CHEK ADVANTAGE MODULE
Chemistry
33d
Cleared
Jun 03, 2002
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
Chemistry
28d
Cleared
Apr 16, 2002
ROCHE ONLINE THEOPHYLLINE
Toxicology
41d
Cleared
Mar 21, 2002
DIABETES ASSISTANT SOFTWARE
Chemistry
94d
Cleared
Mar 06, 2002
ELECSYS ANTI-TG CALCHECK
Immunology
30d
Cleared
Jan 08, 2002
ROCHE ACETAMINOPHEN
Toxicology
56d
Cleared
Dec 21, 2001
ABUSCREEN ONLINE OPIATES 300 / 2000
Toxicology
63d
Cleared
Dec 05, 2001
ACCU-CHEK ACTIVE TEST SYSTEM
Chemistry
135d
Cleared
Nov 30, 2001
INFLUENZA A/B RAPID TEST, CAT NO 2158 663
Microbiology
184d
Cleared
Nov 29, 2001
TINA-QUANT COMPLEMENT C4 TEST SYSTEM
Immunology
127d
Cleared
Nov 29, 2001
TINA-QUANT COMPLEMENT C3C TEST SYSTEM
Immunology
127d
Cleared
Nov 16, 2001
TINA-QUANT APOLIPOPROTEIN B VER.2
Chemistry
52d
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